Assured™ Expectorant Mucus Relief

SPL v5

SPL

SPL Set ID daa57e73-7ebb-4ca7-972f-10856abd0b67

Route

ORAL

Published

Effective Date 2018-03-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Silicon Dioxide Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: EB Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Completed Since 2018-03-15 Until 2022-01-12

Description

Drug Facts

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Drug Facts

Uses

helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50570-1

Do not use

for children under 12 years of age

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

do not crush, chew, or break caplet
take with a full glass of water
adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours.
children under 12 years of age: do not use

Other Information

store between 20-25°C (68-77°F)

Inactive Ingredients

Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Questions Or Comments?

1-888-333-9792

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Ask A Doctor Before Use If You Have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Principal Display Panel 15 Caplet Bottle Carton

ASSURED ™

EXPECTORANT

MUCUS

RELIEF

Guaifenesin 400 mg

Thins &

Loosens

Mucus,

Relieves Chest Congestion

Actual Size

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

Structured Label Content

Uses

helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50570-1 (50570-1)

Do not use

for children under 12 years of age

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Expectorant

Directions

do not crush, chew, or break caplet
take with a full glass of water
adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours.
children under 12 years of age: do not use

Other Information (Other information)

store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Principal Display Panel 15 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton)

ASSURED ™

EXPECTORANT

MUCUS

RELIEF

Guaifenesin 400 mg

Thins &

Loosens

Mucus,

Relieves Chest Congestion

Actual Size

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet) )

Guaifenesin 400 mg

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm(mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222", "50570-1": "Do not use for children under 12 years of age", "53414-9": "If pregnant or breast-feeding, ask a health professional before use. ", "Purpose": "Expectorant", "Directions": "do not crush, chew, or break caplet take with a full glass of water adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 caplets in 24 hours. children under 12 years of age: do not use", "Other information": "store between 20-25°C (68-77°F)", "Inactive ingredients": "Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid", "Questions or comments?": "1-888-333-9792", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.", "Ask a doctor before use if you have": "persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)", "PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton": "ASSURED ™ EXPECTORANT MUCUS RELIEF Guaifenesin 400 mg Thins & Loosens Mucus, Relieves Chest Congestion Actual Size", "Active ingredient (in each caplet) ": "Guaifenesin 400 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:29.984044 · Updated: 2026-03-14T23:00:57.322924